Active Ingredient: Exenatide
Exenatide is indicated for treatment of type 2 diabetes mellitus in combination with:
in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
Exenatide is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these medicinal products.
For this indication, competent medicine agencies globally authorize below treatments:
10 - 20 ug
From 5 To 10 ug 2 time(s) per day every day
Immediate-release exenatide therapy should be initiated at 5 mcg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability. The dose of exenatide can then be increased to 10 mcg BID to further improve glycaemic control. Doses higher than 10 mcg BID are not recommended.
Immediate-release exenatide is available as either a 5 mcg or a 10 mcg exenatide per dose pre-filled pen.
Immediate-release exenatide can be administered at any time within the 60-minute period before the morning and evening meal (or two main meals of the day, approximately 6 hours or more apart). Immediate-release exenatide should not be administered after a meal. If an injection is missed, the treatment should be continued with the next scheduled dose.
Immediate-release exenatide is recommended for use in patients with type 2 diabetes mellitus who are already receiving metformin, a sulphonylurea, pioglitazone and/or a basal insulin. Immediate-release exenatide use can be continued when a basal insulin is added to existing therapy. When immediate-release exenatide is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued as no increased risk of hypoglycaemia is anticipated, compared to metformin or pioglitazone alone. When immediate-release exenatide is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia. When immediate-release exenatide is used in combination with basal insulin, the dose of basal insulin should be evaluated. In patients at increased risk of hypoglycaemia reducing the dose of basal insulin should be considered.
The dose of immediate-release exenatide does not need to be adjusted on a day-by-day basis depending on self-monitored glycaemia. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when exenatide therapy is started and insulin is reduced. A stepwise approach to insulin dose reduction is recommended.
Immediate-release exenatide should be used with caution and dose escalation from 5 mcg to 10 mcg should proceed conservatively in patients >70 years. The clinical experience in patients >75 years is very limited.
Each dose should be administered as a subcutaneous injection in the thigh, abdomen, or upper arm. Immediate-release exenatide and basal insulin must be administered as two separate injections.
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